Infection outbreaks caused by sterile compounding errors have been an ongoing problem, starting with a case in Nebraska in 1990 to more recent ones in Alabama and Tennessee in 2011. The U.S. Pharmacopeia (USP) Chapter <797> was designed to minimize such outbreaks, but it can only be effective when its requirements are strictly followed, and that is not always the case, according to an expert speaking at a webinar sponsored by Wolters Kluwer Health, provider of the USP compliance software Simplifi 797.
USP <797>, which applies to preadministration manipulations of compounded sterile preparations and to all compounding personnel and facilities, was introduced in its first iteration in 2004 and in a revised form in 2008. (The next revision is in process and is slated for completion in 2013.)
Although the <797> guidelines have been in place and there are many levels of oversight governing compounding and dispensing activities—the FDA, state boards of pharmacy, pharmacists and pharmacy technicians—cases of noncompliance do occur, noted webinar presenter Keith H. St. John, MS, CIC, director of clinical epidemiology at Wolters Kluwer Health, in Bellevue, Wash. Because technicians and other pharmacy staff are “directly involved in compounding and dispensing activities … we need to empower [them] to speak up when things are not done according to standard operating procedures,” said Mr. St. John.
According to Eric S. Kastango, MBA, RPh, FASHP, there are particular requirements of <797> that tend to be problem areas for noncompliance.